Pharmacovigilance

Research Services

Maintain patient safety and clinical trial integrity with our comprehensive pharmacovigilance services.

Why choose our partner network?

Pharmacovigilance represents a cornerstone of safety and compliance in the clinical research domain. Triall's pharmacovigilance partners help you protect the safety of your study participants and navigate applicable regulatory requirements with full confidence.

Our approach to pharmacovigilance

Our diverse team brings a wealth of experience in pharmacovigilance across a variety of therapeutic areas, ensuring proactive and seamless safety management in your clinical trial. We meticulously track and analyse safety data throughout every phase of your study, swiftly identifying potential risks and allowing for timely intervention.

Triall has built a network of selected CRO partners who each excel in their respective domain, allowing us to offer you a truly end-to-end service offering. Each partner has undergone a rigorous vendor qualification to ensure our services meet the highest standards.

Adverse Event Monitoring & Reporting

Our services include efficient and timely detection, investigation, and reporting of any suspected adverse events. Through continuous tracking and reporting, our aim is to protect patient safety and ensure the clinical trial's progression remains unhindered.

Signal Detection & Risk Management

Our state-of-the-art eClinical systems allow for proactive detection of potential safety signals, enabling us to effectively implement risk mitigation measures. This allows you to identify potential risks before they become critical limitations to your clinical trial success. Moreover, we can seamlessly conduct all your medical coding activities in accordance with WHODrug and MedDRA dictionaries.

Periodic Safety Update Reports (PSURs)

We support you with drafting and submitting Periodic Safety Update Reports (PSURs) in line with regulatory requirements. Our aim is to help you ensure a thorough evaluation of potential safety issues.

Development Safety Update Reports (DSURs)

We help you prepare and distribute your Development Safety Update Reports (DSURs) to applicable competent authorities. Besides equipping you with a detailed safety analysis, these reports highlight any new emerging risks and outline the steps taken for their mitigation.

Data Safety Monitoring Board (DSMB) setup & management

We have broad experience in organising and managing a Data Safety Monitoring Board (DSMB). By tapping into our global network of investigators and safety experts, we can help you promote and maintain patient safety as well as the scientific integrity of your study outcomes.

EudraVigilance setup & management

Our team of experts can support you with establishing and maintaining your EudraVigilance system. We can manage data entry, ensure regular database maintenance, and perform necessary updates in line with EMA requirements.

Real-time Surveillance

Our advanced monitoring systems allow us to identify safety signals in real-time, thereby facilitating proactive decision-making.

Proactive Risk Mitigation

We help you asses and evaluate potential risks, enabling early intervention strategies that mitigate potential hazards. This proactive approach not only protects patient safety but also safeguards your trial's integrity.

Tailored Solutions

Recognising that each clinical trial is unique, we design pharmacovigilance strategies that align with your study-specific requirement. Our adaptive approach ensures a personalised solution that fits seamlessly into your internal systems.

Regulatory Compliance

Navigating the intricate web of regulatory requirements can be overwhelming. Our deep understanding of regional and international pharmacovigilance requirements ensures that your studies adhere to the latest guidelines.

Comprehensive Reporting

Transparency and open communication are central to our services. We provide comprehensive safety reports that enable you to stay informed about safety trends, emerging concerns, and the overall risk profile of your trial.

Interested in this service?

Our specialists are available to answer your questions. Reach out to us and explore opportunities to match your clinical research needs today.

Did you know we also offer eClinical solutions?